Back to resultsA Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson
Primary Purpose
Parkinson Disease, Gait Disorders, Neurologic
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Virtual reality combined with anti-gravity treadmill
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson, Virtual reality, Anti-gravity treadmill, Rehabilitation, Gait disorders
Eligibility Criteria
Inclusion Criteria:
- Having Parkinson's disease diagnosed by a neurological doctor.
- Having an alteration of the gait caused by the neurological disorder.
- Being able to have an independent and voluntary walk of 10 meters as minimum.
- Height more than 150 cm.
Exclusion Criteria:
- Being blind.
- Medical contraindications for walking.
- Being amputee.
- Alcohol or drugs abuse.
- Other diseases that impedes the intervention.
Sites / Locations
- Asociación de Parkinson de Aragón
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Single-arm
Outcomes
Primary Outcome Measures
Changes in gait autonomy
Changes in gait autonomy will be measured by 6-Minutes Walking Test (6MWT). The 6MWT consists of measuring the maximum distance (in meters) that the subject can walk during 6 minutes in a flat surface.
Secondary Outcome Measures
Changes in gait speed
Changes in gait speed will be measured by 10-Meter Walk Test (10MWT). The 10MWT consists of asking the subject to walk a 14m distance on flat area and measure the time spent from meter 2 to meter 12. Time will be measured by a digital chronometer. Gait speed will be calculated in meter per second.
Changes in balance and gait ability
Changes in balance and gait ability will be measured by Tinetti scale. The Tinetti test is a simple, reproducible way of assessing the risk of falling in the elderly. This scale is composed of two value, static and dynamic: the test grants a maximum of 16 points for static part (sitting) and 12 point for dynamic (walking) part. Higher is the score, better is the performance.
Changes in quality of life
Changes in quality of life will be measured by by 36-Item Short-Form Health Survey (SF-36). SF-36 assesses 8 physical and mental health domains: 1) Physical Functioning, 2) Social Functioning, 3) Role-Physical, 4) Bodily Pain, 5) Mental Health), 6) Role-Emotional, 7) Vitality, and 8) General Health. For each scale, item scores are coded, summed, and transformed, with final values expressed as a percentage, ranging from 0 (worst health) to 100 (best health).
Full Information
NCT ID
NCT04117737
First Posted
October 3, 2019
Last Updated
January 27, 2020
Sponsor
Universidad San Jorge
1. Study Identification
Unique Protocol Identification Number
NCT04117737
Brief Title
A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson
Official Title
Effects of Virtual Reality Combined With Antigravity Treadmill Rehabilitation for Gait Improvement of Patients With Parkinson's Disease: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad San Jorge
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to improve knowledge about mechanical gait assistance combined with virtual reality efficiency in gait recovery for Parkinson´s patients. It is hypothesised that 12 sessions of 30 minutes each, over a 4 weeks period, of antigravity treadmill rehabilitation combined with virtual reality treatment is effective for increase gait autonomy in patients with Parkinson's disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Gait Disorders, Neurologic
Keywords
Parkinson, Virtual reality, Anti-gravity treadmill, Rehabilitation, Gait disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Outcomes assessor was blinded to outcomes values between sessions and to the adherence of participants to the intervention.
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Single-arm
Intervention Type
Other
Intervention Name(s)
Virtual reality combined with anti-gravity treadmill
Intervention Description
The system is composed of three major parts: the treadmill, the antigravity system and the virtual reality system.
The treadmill is the base of the device. It is a rounded and concave structure that permits to walk in all direction. For simulate anti-gravity, a harness and pulley system allow to regulate the weight. Finally, the virtual reality system enables participants to simulate an experience of daily life.
Primary Outcome Measure Information:
Title
Changes in gait autonomy
Description
Changes in gait autonomy will be measured by 6-Minutes Walking Test (6MWT). The 6MWT consists of measuring the maximum distance (in meters) that the subject can walk during 6 minutes in a flat surface.
Time Frame
Baseline and 4-weeks
Secondary Outcome Measure Information:
Title
Changes in gait speed
Description
Changes in gait speed will be measured by 10-Meter Walk Test (10MWT). The 10MWT consists of asking the subject to walk a 14m distance on flat area and measure the time spent from meter 2 to meter 12. Time will be measured by a digital chronometer. Gait speed will be calculated in meter per second.
Time Frame
Baseline and 4-weeks
Title
Changes in balance and gait ability
Description
Changes in balance and gait ability will be measured by Tinetti scale. The Tinetti test is a simple, reproducible way of assessing the risk of falling in the elderly. This scale is composed of two value, static and dynamic: the test grants a maximum of 16 points for static part (sitting) and 12 point for dynamic (walking) part. Higher is the score, better is the performance.
Time Frame
Baseline and 4-weeks
Title
Changes in quality of life
Description
Changes in quality of life will be measured by by 36-Item Short-Form Health Survey (SF-36). SF-36 assesses 8 physical and mental health domains: 1) Physical Functioning, 2) Social Functioning, 3) Role-Physical, 4) Bodily Pain, 5) Mental Health), 6) Role-Emotional, 7) Vitality, and 8) General Health. For each scale, item scores are coded, summed, and transformed, with final values expressed as a percentage, ranging from 0 (worst health) to 100 (best health).
Time Frame
Baseline and 4-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Having Parkinson's disease diagnosed by a neurological doctor.
Having an alteration of the gait caused by the neurological disorder.
Being able to have an independent and voluntary walk of 10 meters as minimum.
Height more than 150 cm.
Exclusion Criteria:
Being blind.
Medical contraindications for walking.
Being amputee.
Alcohol or drugs abuse.
Other diseases that impedes the intervention.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo Herrero, PhD
Organizational Affiliation
Universidad San Jorge
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asociación de Parkinson de Aragón
City
Zaragoza
ZIP/Postal Code
50015
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There are currently no plan on sharing data from this study with other researchers.
Learn more about this trial
A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson
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